CMC Manager Regs - Biotech

NonStop are looking to speak with candidates who are interested to work in the UK who have experience within Regulatory Affairs Manager, we are currently working with one of the largest Biotech's in the world with several exciting projects coming through, to play a fundamental part in. Joining offers many benefits, however it is important to highlight this is a 12 month contract with guaranteed hours, which can give you stability within your work and plan accordingly. Something not so common in the industry.

The role can currently be worked remotely due to the current pandemic, with potentially the option to carry this on post COVID. However, candidates must be based in the UK.

Responsibilities will include:

• Ensuring CMC regional issues impacting global regulatory strategy for proposed CMC

filings are considered and risks identified with appropriate contingency strategies

• Review the preparation of M2 and 3 CMC components of filings and assess fitness of purpose for submission in the relevant countries
• Manages Strategy and Execution for all regulatory submissions (e.g. clinical trial and variations)
• Authoring and coordinating responses to questions across assigned products and countries.
• Point of Contact with local country regulatory staff
• Project management of submissions and monitoring status of applications
• Communicate regional needs for ensuring reliability of the supply chain and successful launch are well defined and implemented in collaboration with relevant regional stakeholders
• Ensure regulatory product compliance for product (e.g. IMR, PMCs, paediatric and other agency commitments)
• Share regulatory information and implications with the stakeholders on an ongoing basis and provide advice on regional considerations

Ideally we are looking for:

We need someone has provided general support for EU/Swiss variations

Experience of emerging markets Russia/Balkans

Clinical (CTA) experience is less important, candidates must have POST APPROVAL experience

Personal that can work independently

Ideally 5 + years in a similar level role

Call me Daniel Watson at NonStop Recruitment now for a confidential conversation. Contact me on D.Watson@nonstop-recruitment.com or 0207 940 2105, please send your CV in word format OR if this does not sound like the opportunity for you, but you are a clinical research professional within the pharmaceutical, medical device or biotech industry, please feel free to get in touch, to see other opportunities we may have within this field.

NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover.